| CTRI Number |
CTRI/2024/09/073424 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effectiveness and safety of microneedling with topical minoxidil 5 percent gel versus microneedling with topical 2 percent tofacitinib gel in alopecia areata |
|
Scientific Title of Study
|
Comparative study of therapeutic efficacy and safety of microneedling with topical minoxidil 5 percent gel versus microneedling with topical 2 percent tofacitinib gel in alopecia areata |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harmandeep Kaur |
| Designation |
Post graduate student |
| Affiliation |
Guru Gobind Singh medical college and Hospital, Faridkot |
| Address |
Department of Dermatology, Venreology and Leprology, Guru Gobind Singh medical college and Hospital, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
7973262698 |
| Fax |
|
| Email |
kaurharmandeep286@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amarbir Singh Boparai |
| Designation |
Associate Professor |
| Affiliation |
Guru Gobind Singh medical college and Hospital, Faridkot |
| Address |
Department of Dermatology, Venreology and Leprology, Guru Gobind Singh medical college and Hospital, Faridkot
PUNJAB
151203
India |
| Phone |
9815450502 |
| Fax |
|
| Email |
amarbirboparai@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harmandeep Kaur |
| Designation |
Post graduate student |
| Affiliation |
Guru Gobind Singh medical college and Hospital, Faridkot |
| Address |
Department of Dermatology, Venreology and Leprology, Guru Gobind Singh medical college and Hospital, Faridkot
PUNJAB
151203
India |
| Phone |
7973262698 |
| Fax |
|
| Email |
kaurharmandeep286@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Gobind Singh medical college and Hospital, Faridkot Punjab, India. Pin code 151203 |
|
|
Primary Sponsor
|
| Name |
Dr. Harmandeep Kaur |
| Address |
Department of Dermatology, Venereology and Leprology, Guru Gobind Singh medical college and Hospital, Faridkot |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harmandeep Kaur |
Guru Gobind Singh medical college and Hospital, Faridkot |
Room Number 2, Department of Dermatology, Leprology and Venereology, Guru Gobind Singh medical college and Hospital, Faridkot
Faridkot
PUNJAB |
7973262698
kaurharmandeep286@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Thesis and ethics committee, Guru Gobind Singh medical college and Hospital, Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L638||Other alopecia areata, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Microneedling with topical 2% tofacitinib gel |
2% tofacitinib gel will be used instead of 5% minoxidil gel and rest whole procedure will be done as in intervention.
A total of 3 sittings will be done at an interval of 3 weeks each. |
| Intervention |
Microneedling with topical minoxidil 5% gel |
5% minoxidil gel (amount depending on area to be covered) will be applied on the selected patches of alopecia areata followed by microneedling using microneedle having 1.5 mm needle depth. Microneedle will be moved on the patches diagonally, vertically and horizontally in each direction after applying 5% minoxidil. This will create pin point bleeding which will be taken as an end point, following
which 5% minoxidil will be applied again. The patients will be asked to apply 5% minoxidil over the affected area, two times a day at home in between the sessions.
A total of 3 sittings will be done at an interval of 3 weeks each. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18-50 years of age with limited patches of alopecia areata (upto 5 patches).
2.Patients who are willing to sign the written consent form prior to participation in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patient having history of hypersensitivity to minoxidil or tofacitinib.
2.Active scalp infection.
3.Subjects with history of bleeding, platelet disorders.
4.History of uncontrolled diabetes mellitus and hypertension.
5.Pregnant and lactating females.
6.Immunocompromised patients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction in SALT score
2. Dermoscopic and photographic improvement |
At the starting of the treatment, at every visit and 4 weekly for next 16 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of microneedling with topical minoxidil 5 percent gel versus microneedling with topical 2 percent tofacitinib gel using adverse drug reaction form |
At every visit & 4 weekly for next 16 weeks. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Alopecia areata is an autoimmune condition presenting as smooth, sharply
demarcated, round patches of hair loss without atrophy with “exclamation
mark hairâ€. AA
is caused by an autoimmune reaction to the hair follicles due to both genetic
and environmental factors.
Various treatment modalities are used for AA including
minoxidil, topical and systemic steroids, tacrolimus, topical
dithranol, tretinoin, PUVA therapy,
oral immunosuppressive drugs and contact immunotherapy. The present study is being conducted
to compare the therapeutic efficacy
and safety of microneedling
with topical minoxidil 5% gel versus microneedling with topical 2% tofacitinib gel in limited patches
of alopecia areata
(upto 5 patches). |